Executive Director - Regulatory Affairs
September 16
Description
• Develop and execute global regulatory strategic and tactical guidance for innovative drugs • Key member of the Regulatory team • Develop regulatory direction and mentorship on projects • Manages interface with outside regulatory agencies • Accountable for preparation, submission and maintenance for product specific dossiers • Ensure compliance with product post marketing approval requirements • Assess regulatory impacts associated with changes made in the development of products • Provides leadership with global regulatory strategy teams • Ability to travel 15-20% domestic and internationally
Requirements
• Bachelor’s degree in a scientific discipline • Master’s degree preferred • 12+ years of increasing Regulatory Affairs experience • 6+ years of supervisory/management experience in biotech or Pharmaceutical industry • Demonstrated track record of successful approvals from a major regulatory agency • Prior regulatory agency liaison experience • Excellent written and communication and interpersonal skills
Benefits
• premium health • financial • work-life • well-being offerings for eligible employees and dependents • wellness and employee support programs • life insurance • disability • retirement plans with employer match • generous paid time off
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